Senior Document Control Specialist - GMP & Quality

integer

Plymouth (MN)

On-site

USD 34,000 - 50,000

Full time

2 days ago
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Benefits offered by this job

Medical, Dental, Vision
Disability Insurance
Life Insurance
Adoption Benefits

Job summary

Integer seeks a Documentation Administrator to support GMP-compliant records management within the Quality function. You will ensure controlled documents flow, manage access, and assist audits while training staff on systems and methods.

In this role you will uphold GDP, review Device History Records, and drive process improvements. The position emphasizes collaboration, adherence to QMS, and ownership of quality in daily work.

Qualifications

  • Minimum Education: Diploma / or equivalent in administration preferred.
  • Minimum Experience: 4+ years of experience in administration in a GMP setting.
  • Special Skills: Leadership; guidance for junior team members and other users.
  • Effective communication, both oral and written, to convey complex information.
  • Strong organizational skills and ability to prioritize and meet deadlines.
  • Proficient use of MS Teams, Excel and Word; attention to detail in document review.

Responsibilities

  • Support and perform documentation administration activities within the Quality function in GMP environment.
  • Adhere to QMS, EMS, FDA regulations and company policies in location.
  • Provide administrator support for change record implementation per SOPs.
  • Control distribution and retrieval of documents, both electronic and hard copy.
  • Notify functions when local external documents change as required.
  • Manage access to on-site and off-site records and documents.
  • Perform annual record disposition review.
  • Compile quality records and reports ensuring GDP.
  • Review Device History Records per procedures and GDP.
  • Assist Quality during audits and provide guidance to other departments.
  • Train personnel in system usage and processes; expand skill base on the job.
  • Grow on the job and help others succeed; align with corporate initiatives.
  • Identify and escalate quality non-conformances; drive improvements.

Skills

Leadership
Communication
Time management
Problem solving
Attention to detail
Organizational skills

Education

Diploma in administration

Tools

Microsoft Teams
Excel
Word
Electronic documentation systems

Job description

Integer seeks a Documentation Administrator to support GMP-compliant records management within the Quality function. You will ensure controlled documents flow, manage access, and assist audits while training staff on systems and methods.

In this role you will uphold GDP, review Device History Records, and drive process improvements. The position emphasizes collaboration, adherence to QMS, and ownership of quality in daily work.

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